Cleared Traditional

SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER

K132153 · Nipro Medical Corporation · General Hospital

Dec 2013

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K132153 is an FDA 510(k) clearance for the SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on December 5, 2013, 146 days after receiving the submission on July 12, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K132153 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2013
Decision Date	December 05, 2013
Days to Decision	146 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200